MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE 6 MM CYLINDRICAL BUR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number ROB10036

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Our reference number: case-(b)(4).

Event Description

It was reported that when they burred the distal ap rotation holes on "off" cutting mode during a cori tka procedure, they were using a 6 mm bur and the holes were 5 mm.They forgot that they were still in the "off" mode, and went to check out checkpoints, and then the cori prompted after the femur checkpoint verified, that they were still on "off" (there was a warning that they were still in the "off" mode when they went back to recut).After verifying the checkpoints, they remembered that they were in "off " mode and they switched back to speed control.There was not significant enough bone removed in "off" mode to impact patient outcome during the procedure.No other complications were reported.

Manufacturer Narrative

Section d of suspect medical device was updated.Our reference number: (b)(4).

Manufacturer Narrative

H3, h6: the ri 6 mm cylindrical bur, rob10036 used for treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be confirmed.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.A capa, hhe/pra, field action review was not completed.The product was not returned and no evidence was made available to link the complaint to a capa, hhe/pra, field action.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may be associated with surgical technique.If speed or exposure mode is not used, and the choice is made to proceed with control modes off, the robotic drill will not stop cutting bone when the target surface is reached.It is the responsibility of the surgeon to control the cutting depth when speed or exposure mode is not employed.This failure is an identified failure mode within the risk assessment.The medical investigation found that it was reported that during burring of the distal femur the surgeon was having a hard time burring past the green layer and the surgeon noticed that the guard was loose/sliding forward off the long attachment ¿hindering the bur from extending all the way out to cut the desired depth¿ resulting in an undercut (case-(b)(4)).However, it was also reported that the burr used was a 6mm cylindrical and the holes were 5mm.No patient injury and no surgical delay was reported, and the procedure was completed with the same device.Based on the information provided, the procedure was successfully completed without patient injury/harm or surgical delay; therefore, no further medical assessment is warranted at this time.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: REAL INTELLIGENCE 6 MM CYLINDRICAL BUR
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11319073
• MDR Text Key: 231583775
• Report Number: 3010266064-2021-00098
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB10036
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention